Results of three Phase II Trials in Lung Cancer Indications Confirm Safety and Antitumour Activity of NGR-hTNF

S.p.A. IM today reports new clinical data of its investigational anticancer drug NGR-hTNF in three different lung cancer indications, which will be presented on 4 June at the 47th ASCO Annual Meeting in Chicago. Initial analysis of a randomised Phase II trial in non-small cell lung cancer, along with top line results of a Phase II trial in small-cell lung cancer and long-term follow up of a Phase II trial in mesothelioma, confirm the favourable safety profile as well as the promising antitumour activity of NGR-hTNF. Claudio Bordignon, MolMed's chairman and CEO, comments: "These new data represent another important milestone in the development of NGR-hTNF and show our commitment in the treatment of pulmonary tumours, from mesothelioma to non-small cell and small cell lung cancers. These are the results of a intense and diversified effort in clinical development: we have now ongoing several trials including a pivotal Phase III trial in mesothelioma and a randomised Phase II trial in non-small cell lung cancer. In the treatment of mesothelioma, we expect to have the final results of the Phase III study in 2013, while the results of the long-term analysis of the completed Phase II study confirm the efficacy of our treatment-intensification strategy. In non-small cell lung cancer, the first evaluation of the randomised Phase II trial suggests antitumour activity that is particularly evident in patients with squamous histology, and in patients with adenocarcinoma who received maintenance treatment with NGR-hTNF after completion of chemotherapy. These are important results, because this evidence, together with the lack of cumulative toxicity, led us to explore a new treatment option for NGR-hTNF as maintenance therapy. The first application of this new approach is represented by a randomised Phase II trial of first-line therapy in mesothelioma now open for patient accrual."